Ketamine-assisted integrative treatment for Veterans with chronic low back pain and depression
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
This pilot tests whether ketamine infusions followed by a brief behavioral program can reduce pain interference and improve mood in Veterans with chronic low back pain and depression.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06419439 on ClinicalTrials.gov |
What this trial studies
The project first enrolls a small open-label group of five Veterans to pilot ketamine infusions followed by a brief narrative behavioral intervention and collect participant feedback and safety data. After initial refinement, the study proceeds to a single-blind, two-arm pilot randomized trial with 44 Veterans (22 per arm) comparing the combined ketamine-plus-behavioral approach to minimally enhanced usual care. Primary aims are feasibility, acceptability, and safety, with semi-structured exit interviews used to refine procedures. Outcome data from the pilot will be used to calculate sample size for a larger randomized trial targeting pain interference and depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are English-speaking Veterans with moderate-to-severe, high-impact chronic low back pain and current significant depressive symptoms who are medically stable, have had no recent medication changes, have no planned new procedures during the four-month study, and can arrange an adult to drive them home after ketamine treatments.
Not a fit: Patients who are non-English speakers, medically unstable, recently hospitalized, planning surgery or new pain/depression interventions, unwilling to maintain stable medications, or unable to secure transportation after infusions may not be appropriate or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this combined approach could reduce pain-related interference and depressive symptoms, improving daily function for participating Veterans.
How similar studies have performed: Prior controlled trials show ketamine can produce rapid antidepressant effects and some short-term pain relief, but combining ketamine infusions with a brief narrative behavioral intervention for Veterans with chronic low back pain and depression is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR). * Medically stable (no hospitalizations in the past month lasting 3 days). * No changes in pain or depression medication regimen in 4 weeks. * No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration). * Participants must have an adult who can drive them home after the ketamine treatments. Exclusion Criteria: * Inability to speak English due to the narrative intervention being conducted in English. * Inability or unwillingness to provide written informed consent (e.g. current delirium). * Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder. * Currently participating in another clinical trial for pain or depression. * Current uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg). * Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure. * History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure). * Any of the following lab values \>2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) \<2x lower limit of normal or \>2x upper limit of normal. * Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential. * Known hypersensitivity to any excipient in the ketamine injection formulation. * Previously experienced serious adverse effects with ketamine. * On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine * Current or previous abuse of ketamine.
Where this trial is running
Ann Arbor, Michigan
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Victoria D Powell, MD — VA Ann Arbor Healthcare System, Ann Arbor, MI
- Study coordinator: Victoria D Powell, MD
- Email: Victoria.Powell2@va.gov
- Phone: (734) 845-3072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.